In Brief: Amici Provide Reasons to Reconsider Ariosa v. Sequenom

[This post includes links to the 12 amicus briefs supporting Sequenom’s petition for en banc rehearing in this Subject Matter Eligibility Case.]

by Dennis Crouch

Ariosa Diagnostics, Inc v. Sequenom, Inc. (Fed. Cir. 2015) (en banc petition 2015)

This subject matter eligibility case revolves around an important scientific discovery that a pregnant woman’s blood plasma/serum contains fetal DNA and that the fetal DNA can teased-out by amplifying paternally-inherited sequences from the cell-free fractions of the mother’s blood. Sequenom’s patents focus on methods of prenatal genetic diagnoses that rely upon these discovery by the inventors. U.S. Patent No. 6,258,540.

Invalid: Applying Mayo v. Prometheous, the Federal Circuit held all the claims in-suit to be ineligible. In step one of the Mayo inquiry, the court found that the claims were all directed to a natural phenomenon: the existence of paternally-inherited cell-free fetal DNA (cffDNA) in the maternal bloodstream. In step two, the search for an ‘inventive concept,’ the court found that the practical implementation of the natural phenomenon was insufficient because it merely involved well known methods of amplifying DNA.  (CitingFlook).  Without an inventive concept beyond the excluded subject matter – the claims were left ineligible for patent protection.

In his usual understated approach, Professor Chris Holman identified the Federal Circuit decision “not good news for innovation in the life sciences.”  The USPTO has also seemingly delayed providing examiner’s with guidance on how to implement Ariosa during examination.

En Banc Rehearing Petition: The patentee has now put forward a strong move for rehearing en banc  with a well drafted petition and support from a host of amici. Aptly describing the core issue, Sequenom’s counsel Tom Goldstein explains:

[Under the Federal Circuit’s rule] the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel. . . . that cannot be correct.

Read the Ariosa.Petition.  The petitioner’s main argument here is with the Supreme Court’s broad language used in Mayo that also revitalized Flook.  Of course, those cases conflict with other Supreme historic precedent. In the coming months, the Federal Circuit will decide this en banc request, but the case is very much being set-up for Supreme Court review.

The 12 amicus briefs filed in support of the petition are strong and well written.

My former boss Kevin Noonan is counsel of record for a group of 23 law professors, including Adam Mossoff, Dan Burk, Tim Holbrook, and Richard Epstein. The brief makes two main arguments: (1) the genetic diagnostic tests developed and commercialized here are the type “historically unforeseen invention” that the patent system is designed to promote; and (2) the panel’s approach here of requiring novelty beyond straightforward application of excluded natural phenomenon “would call into question nineteenth century patented innovation the Supreme Court deemed valid.”Read Ariosa.lawprof.  The sentiment of the Law Professor Brief is consistent with the brief filed by Matthew Dowd on behalf of JYANT Tech, explaining that “in Diamond v. Diehr … the [Supreme] Court explained that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.” Read Ariosa.JYANT

As we will discuss in a parallel post, the brief of Professors Lefstin and Menell provide their reading of recent Supreme Court cases of Mayo and Alice — arguing that (1) a close reading shows that inventive application of a law of nature is not required but instead a non-preemptive or non-generic application; and (2) the Flook-type claim dissection is prohibited. Read Ariosa.Leftsin. This analyze-it-as-a-whole sentiment was repeated by the IPO Brief field by Tiege Sheehan as well as the brief from Amarantus filed by Gideon Schor. Read  Ariosa.IPO and Ariosa.Amarantus.

My Fellow Missouri Professor Chris Holman filed a brief on behalf of the major industry organizations BIO and PhRMA making the credible argument that all this is a very big deal in the diagnostic space and that the resulting uncertainty is having a negative impact on research. Read Ariosa.BIO.

Preemption: When the Supreme Court explained its two two-step approach in Mayo andAlice, it noted the purpose was to avoid preemption of any excluded subject matter — that is, to ensure that no single entity could claim exclusive sovereignty over an abstract idea, law of nature, or natural phenomenon.  Rather, those basic fundamentals of society should not be subject to private claims of right.  Although the purpose behind the test is preventing this preemption, the test itself seemingly does not ask whether preemption has occurred. In its brief, the NYIPLA argues that this fundamental question of preemption must be asked and the Mayo/Alice framework does not authorize a court to ignore that inquiry.READ Ariosa.IPLA.  This focus on preemption is repeated by WARF’s brief filed by Dan Bagatell — writing that “the critical question is whether a patent impermissibly claims and prevents others from using a natural phenomenon, law of nature, or abstract idea itself, or instead permissibly claims a practical application of one of those things.”Read Ariosa.WARF.

Myriad‘s counsel Benjamin Jackson filed a brief on behalf of the industry organization21st Century Medicine that challenges the “gist” method of determining whether a claim encompasses excluded subject matter and suggests that the claim here is simply a technological improvement over the prior art.

Sequenom’s patent teaches it was known in the art that fetal cells can pass into the mother’s blood. Diagnostic techniques had been devised to isolate these cells and analyze fetal DNA extracted from them, but these techniques were expensive and time consuming. The phrase “cell-free fetal DNA” was therefore not an attempt to claim a natural phenomenon but instead a key claim limitation to distinguish over the art. Fifteen years ago, back when patent claiming and examination focused on prior art rather than ill-defined “natural phenomena,” Sequenom appropriately emphasized that its methods used cell-free fetal DNA rather than the cell-derived fetal DNA known in the art.

Thus, the claimed invention is a significant technical improvement in the laboratory process for prenatal diagnosis, allowing laboratories to eliminate the costly and labor-intensive step of isolating fetal cells and then fetal DNA. Such an inventive improvement to the technical performance of an existing technological process is precisely what patents are for.

Read Ariosa.21st. The Novartis brief, filed by its in house counsel Corey Salsberg, makes the important point eligibility has become a tougher test that patentability (nonobviousness). Read Ariosa.Novartis.

Taking a more international approach,Paul Cole and Donald Zuhn teamed-up to file a brief indicating, inter alia, that the panel’s approach in Ariosa creates a potential TRIPs Violation. “This case is an example of an internationally discordant, not harmonious, result, contrary to the eligibility requirements of TRIPS Article 27.”  Read Ariosa.COLE. Similarly, the Bioindustry Association (BIA) also argues that the panel’s approach here means that U.S. eligibility is substantially narrower than that of our global trading partners. Read Ariosa.BIA.

The Federal Circuit may take several weeks to decide this en banc petition. This case is a hot potato and the court’s likely reason for ducking the case would be to avoid being scalded.

 

96 thoughts on “In Brief: Amici Provide Reasons to Reconsider Ariosa v. Sequenom

  1. 16

    Does anyone know if any briefs were filed in opposition to Sequenom’s petition? If yes, how many, and by whom?

  2. 15

    “(1) a close reading shows that inventive application of a law of nature is not required but instead a non-preemptive or non-generic application”

    They are correct about that, but I have to wonder what other wonders of modern medicine these folks propose also can be done with the idea/discovery behind this. If there be a substantial number of other things then yes, I have to agree with them, their claim be eligible.

    1. 15.1

      what other wonders of modern medicine these folks propose also can be done with the idea/discovery behind this

      Not sure what you mean by “other.”

      Nothing is being done “with” this discovery by this claim.

      The claim protects the re-detection of the discovery itself. That’s why it’s ineligible junk.

      Does that mean that the underlying discovery wasn’t important? Heck no! I applaud the discovery. [CLAP CLAP CLAP CLAP CLAP]. Give these guys a prize. Invite them to your conference. Take them out for a steak dinner. Buy ’em a drink. Polish up a nice Wiki entry. Carve their names in granite and name a building after them.

      But keep that junky claim out of the patent system. It doesn’t belong there.

      Just because some fact is “important” or “valuable” doesn’t mean it automatically deserves to be owned by a private individual for fifteen years. More importantly, patent-worthy technologies for detecting stuff — like the PCR technology used to make this discovery — shouldn’t be tied up in “detect this” patents for half a century or longer. That’s what this case is about.

  3. 14

    The late Judge Pfaelzer laid out an approach to analysis of software patent eligibility that might also be helpful at analyzing biotech patent eligibility. For part one of the Mayo analysis, she held that the court “must identify the purpose of the claim — in other words, what the claimed invention is trying to achieve — and ask whether that purpose is abstract.” CalTech v. Hughes Comms., 13-cv-07245, Dkt. 155, at 24.

    It seems to me that even a claim that incorporates a natural as its starting and end point is not necessarily directed to an abstract purpose. Diagnosing particular types of genetic issues in fetuses is about as far from an abstract purpose as you can get. Her purposive approach to part one of the Mayo analysis also helps reconcile Diehr with Bilski and Mayo. The Diehr majority, in effect, took her purposive approach.

    1. 14.1

      While a small isolated portion of the Diehr software was performing an operation (calculating values according to the Arrhenius equation) computable by a human being using a pencil-and-paper method, the totality of the software associated with the Diehr ‘142 claims was obviously not equivalent to a Turing machine because it was controlling devices that took heat measurements and because it controlled devices that opened molds at optimal moments in the rubber curing process.

      Already back in the 1930s before there were electronic computers, mathematical logicians like Church and Turing developed a framework (e.g., Church Turing thesis) useful for addressing issues of patent-eligibility of claims involving a software component.

      BTW, at the time I could have designed a rubber curing device that did exactly what Diehr’s system did without a single digital component. It would obviously have been an improvement on a statutory device, and I could certainly at the time have written patent-eligible allowable claims for my non-digital device.

      Perhaps the prosecutors did not make that point clear to the primary examiner, but I can’t see why the examiner would have rejected claims involving digital components under § 101 while comparable claims for a more traditional purely analog system would obviously have passed muster under § 101 and almost certainly have been allowable.

      1. 14.1.1

        I understand your point about Diehr. The late Justice Stevens seems to have had the same thing in mind in his dissent. But the purpose of the claimed invention at issue in Diehr seems quite tangible to me, despite your point.

        Do you believe that Alice stands for the proposition that all software patents (or even all software business method patents) are now invalid under Section 101?

        1. 14.1.1.1

          Just FYI, Justice Stevens is still alive. He is not the “late” Justice Stevens, just the retired Justice Stevens.

    2. 14.2

      Martin, “abstract” has become a nonce word for two phenomena: subject matter that is non statutory in first place such as “information;” and. second, for otherwise statutory subject matter claimed at the level of an idea.

      Mayo (Funk Bros.) dealt with branch of non statutory subject called laws of nature that are non statutory because they are facts, information that preexisted their discovery.

      Both Mayo and Funk Bros. required some inventive application of the discovered fact to justify a patent. Simply surrounding the discovery on all sides with the routine “may” not be enough unless, like in Diehr, the application of the discovery to the process or machine improves it as a process. Otherwise, the patent is on the discovery itself, but limited to the “use” of a preexisting process without actually improving that process.

      1. 14.2.1

        I think I agree with you. But what do you mean more precisely by “claimed at the level of an idea”? That seems to be the thorny issue. How do we clearly and consistently identify otherwise statutory subject matter that is claimed at too high a level of abstractness?

        I think the purposive approach suggested by Judge Pfaelzer is not the worst that could be adopted.

        1. 14.2.1.1

          Martin, “at the level of an idea” is another way of saying that one is claiming a result. The lingo first appeared in Le Roy v. Tatham, was the basis for the holdings in Morse, Rubber-Tip Pencil and Benson.

          From Tatham,

          “A patent is not good for an effect, or the result of a certain process, as that would prohibit all other persons from making the same thing by any means whatsoever. This, by creating monopolies, would discourage arts and manufactures, against the avowed policy of the patent laws.”

          From Morse:

          “Whoever discovers that a certain useful result will be produced, in any art, machine, manufacture, or composition of matter, by the use of certain means, is entitled to a patent for it; provided he specifies the means he uses in a manner so full and exact, that any one skilled in the science to which it appertains, can, by using the means he specifies, without any addition to, or subtraction from them, produce precisely the result he describes. And if this cannot be done by the means he describes, the patent is void. And if it can be done, then the patent confers on him the exclusive right to use the means he specifies to produce the result or effect he describes, and nothing more.”

          From Rubber-Tip Pencil

          “A patent may be obtained for a new or useful art, machine, manufacture, or composition of matter, or any new and useful improvement thereof. In this case, as has been seen, Blair’s patent was for “a new manufacture,” being a new and useful rubber head for lead-pencils. It was not for the combination of the head with the pencil, but for a head to be attached to a pencil or something else of like character. ”

          “What, therefore, is left for this patentee but the idea that if a pencil is inserted into a cavity in a piece of rubber smaller than itself the rubber will attach itself to the pencil, and when so attached become convenient for use as an eraser?

          An idea of itself is not patentable, but a new device by which it may be made practically useful is. The idea of this patentee was a good one, but his device to give it effect, though useful, was not new. Consequently he took nothing by his patent.”

          From Benson,

          “It is conceded that one may not patent an idea. But in practical effect that would be the result if the formula for converting BCD numerals to pure binary numerals were patented in this case. The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself.”

          Typically, one does not overtly claim simply an idea. One surrounds the novel subject matter with the generic and old. But the novel subject matter is expressed as a result to be achieved without specifying any inventive means or methods for achieving that result. Thus the claim covers all of them, thereby preempting all uses, all applications and all new inventions in the future for achieving the claimed result.

  4. 13

    I assume that the amici assert the idea that scientific discoveries should be patent eligible, independent of any new machine, composition of matter, or process.

    If they are not arguing that, someone should ask them under what circumstances scientific discovery is not patent eligible.

    1. 13.1

      If one discovers great new truths like General Relativity, one might become a Nobel prize winner.

      Shockley won the Nobel prize because he discovered and explained natural phenomena.

      Schockley received patents that claimed innovative devices, e.g., “Semiconductor amplifier”.

      link to google.com

    2. 13.2

      Mr. Snyder, I do not think that you are implying the “independent of” part of your statement correctly.

      No one is making the strawman argument of a discovery so “independent” of any statutory category.

      No one.

      What is going on though is a debate as to things that DO meet the statutory category – as well as meets the other aspect of 101: having the proper utility – but are still being kept out of the “patent eligibility” game by judicial edict.

      There is a world of difference between the so-called “nominalist” position and the anti-nominalist position in which the exception swallows the rule and you effectively have removed a portion of the statute.

      1. 13.2.1

        “independent” means there is no apparatus involved (e.g. theory of relativity) or there is old/known apparatus involved (e.g a telescope).

        There are discoveries that are intimately involved (i.e. not independent)with new or non-obvious apparatus (e.g. using electrodes to purify aluminum) which easily meet machine, composition, and process prongs.

        The amici are apparently arguing that the discovery alone is enough, so long as the discovery has some connection to a machine, composition or process, regardless of the centrality or patentability of those patent-eligible elements.

        Its hardly different than the argument that merely citing a microprocessor makes some software instruction a machine claim.

        So, which kind of discovery is NOT patent eligible?

        1. 13.2.1.1

          You see, there is where the “logic” goes off the rails: or there is old/known apparatus involved

          You are simply over (and mis-) applying that.

        2. 13.2.1.2

          And let me add – as I have so noted many times – that the Claim as a Whole doctrine already takes care of the “non” problem of mere aggregation type claims – whether or not those mere aggregation type claims have elements sounding in “mental steps.”

          It takes just a little inte11ectual honesty to recognize and integrate this in any meaningful dialogue going forward.

      1. 13.3.1

        Can’t you patent a discovery?

        Whoever invents or DISCOVERS any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

        1. 13.3.1.1

          Throw on there 35 USC 100(a):

          The term “invention” means invention or discovery.

          This is an inclusive rather than exclusive action.

          Apparently, Ned never made it through that section of the law…

            1. 13.3.1.1.1.1

              First, your question here is a non sequitur to the point of law under discussion.

              Second, there is no “again,” as you have never asked this question of me.

              Since the question is in fact a non sequitur, and is rather pointless to this discussion, it has been dismissed without further comment.

              Maybe Ned, you want to take a stab at explaining what 35 USC 100(a) – you know, the actual words of Congress means in the world of Ned-IMHO-law land…

            2. 13.3.1.1.1.2

              “Explain to me again how one discovers something that never before existed?”

              You can’t Ned. THAT’S THE POINT.

              “New” doesn’t mean never existed. New means not previously known or used by others.

              If new means never existed, then we can’t possibly allow patents for anything. How can we know what the Romulans have already come up with?

              Is Crestor patenable? How do we know it doesn’t occur naturally in a cave in the Cydonia region of Mars?

              1. 13.3.1.1.1.2.1

                “New means not previously known or used by others.”

                Hardly. Jefferson added “new” to a statute that already had “not know or used.”

                1790: “useful” “manufacture, etc.” “not known or used”

                1793: “new” “useful” “manufacture, etc.” “not known or used.”

                1. Here I agree with Ned. I know that there is case law (In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A. 1970)) that says that “new” in §101 is the same as novel for §102 purposes, but I think that this is simply wrong.

                  The right way to understand this is that natural products can be “novel” in the §102 sense (not known, used, on sale, or described in a printed publication or patent application), without being “new” in the §101 sense. Once you see it like this, you realize that the “judicial exceptions” to §101 are not really “exceptions,” so much as they are careful readings of the statute.

                  “Abstract ideas” are not §101 eligible because they are not machines, manufactures, processes, or compositions of matter.

                  Ditto for “laws of nature.”

                  “Natural products” are not §101 eligible because they are not “new” in the §101 sense.

                  Of course, this is why software (at least as embodied in a Beauregard style tangible medium or considered as a process) should be properly understood as §101 eligible.

                  Similarly, this is why (at least some) isolated biomolecules should also qualify as §101 eligible (because at least some have not existed previously in nature).

                  As for why we do not negative patentability on the basis of a hypothetical existence on Mars, I would say that this simply comes down to the doctrine of prima facie rejections in the PTO, the presumption of validity in court, and the burden of proof. If you really could prove that Crestor was found naturally in a cave in the Cydonia region of Mars, then Crestor really would be unpatentable. But it is not the patent owner/ applicant who must prove that the claim is eligible. Rather, it is the challenger/examiner who must prove that it is not §101 eligible.

                2. Greg, thanks for the support. What I have been saying about 101 was once well understood law.

                  But “abstract?” I think it is being used to an a nonce word to describe subject matter that is neither a new or improved, a machine, manufacture, etc., or a process of making these, or of using these to produce a new, physical result.

                3. What is omitted from Ned’s “careful analysis” is the fact that 1952 came along.

                  But aside from that, there could be a quaint discussion of the patent laws of 1790 and 1793…

                  I just don’t trust Ned’s “version” of anything – he has shown himself unable (or unwilling) to be objective,

                4. ” Once you see it like this, you realize that the “judicial exceptions” to §101 are not really “exceptions,” so much as they are careful readings of the statute.”

                  Once you see it like this, you are through the looking glass.

                  As you point out, there is case law (In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A. 1970)) that says that “new” in §101 is the same as novel for §102 purposes. I think this is right, as it has to be. Which is why the Judicial Exceptions are nonsense.

                5. Fair enough, Les. You are quite right that the case law is on your side and against the way that either Ned or I read §101 (I am not sure that Ned and I are reading it the same way, but the case law is against both of us in any event).

                  On the other hand, the case law if very much against you on the subject of (so-called) “judicial exceptions.” I guess I do not see why it is “through the looking” glass to regard a new species of frog or the mere idea of E=mc^2 to be §101 ineligible. Do you care to explain further why you think the “judicial exceptions” to be nonsense?

                6. Greg, the Supreme court in Myriad held that isolated DNA was not a new composition though previously unknown.

                  The Supreme Court in Flook observed that laws of nature were not new though previously unknown.

                  Discovery of these is not invention.

                  Bergstrom is not good law and has been overruled.

  5. 12

    The desire to patent a pre-existing truth and the application of standard techniques thereto constitute exactly the problem we see with covered business methods.

    Consider “Patenting business methods and software still requires concrete and tangible descriptions”.

    link to ipwatchdog.com

    From Bilski Blog.

    link to bilskiblog.com

    But when it comes to business methods, we see the killer statistics: prior to Alice, prosecutors overcame the non-final § 101 rejections generally about 62% of the time, leading to final rejection rates in the 23-46% range; thus prosecutors had more or less even odds of getting over the rejection. What is shocking is that after Alice, the final rejection rate soared into the 90% range. If you felt frustrated that your crafted (or crafty) arguments failed to impress the Examiner, get in line.

    Boes ‘056 (the Signature Financial Group Patent) should have been held invalid under §101 because it is an obvious example by the Church-Turing thesis of a pre-existing pencil and paper calculation that has been computerized.

    The data above suggests that Alice Corp. v. CLS Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014) has completely overturned State Street Bank and Trust Company v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998).

    I don’t understand why “inventors” keep trying to patent the computerization of mathematical formulas used for managing escrow, arbitrage, portfolio optimization, hedging, etc. — procedures or methods that obviously should not be patent-eligible — when there are business applications in loan management, securitization, and trading for which claims directed toward business methods could be allowable under §101.

  6. 11

    As asked on the blog that disappeared, is not a key question here the following 2 realated questions? (1) Was or was not it unobvious to a POSITA at the invention date [this being a pre-AIA patent] to EVEN LOOK for “paternally-inherited CELL-FREE fetal DNA (cffDNA) in the maternal bloodstream,” and (2) has that question been sufficiently decided below on a 101 S.J. or does it deserve a remand for at least a partial trial on that disputed issue?
    BTW this reminds me of the Australian doctor denied credibility by the medical profession for years who discovered that many of the stomach ulcers then being surgically operated on were caused by a bacteria that could be simply cured by a known antibiotic. I doubt if he got a patent either?

    1. 11.1

      Note that if the answer to question 1 is no, this case could be decided on 103 rather than 101.

      1. 11.1.1

        Mr. Morgan,

        The (all-too-often and mindless) rejoinder to your immediate point is the “whatever” conflation that was attempted – and soundly denied – by the Court itself.

  7. 10

    Prior art diagnostic techniques comprised at least two critical steps: (1) isolation of cells containing fetal DNA; and (2) extraction of fetal DNA from the isolated cells. These steps, which were expensive and time consuming, became unnecessary when naturally occurring cell-free fetal DNA was discovered. Since the patent merely claims analysis of such DNA through conventional amplification of gene sequences, it lacks an “inventive concept” and improperly attempts to preempt a discovery of nature for diagnostic purposes.

  8. 9

    As an initial matter, it’s great to see some of the world’s leading failures in the understanding of subject matter eligibility lining up to defend these junk claims! Eventually Kevin Noonan is bound to get something right, I suppose. Since he made such a magnificent effort to squelch his own understanding of subject matter eligibility and why it exists, and because his blog continues to go to extraordinary lengths to mislead people at every turn, I can’t wish him any luck. He’ll definitely need some luck, however. Thankfully for him (as he’s proudly informed everyone) he’ll still make plenty of money either way because (for reasons that aren’t clear to me) people pay him to “explain” stuff. Isn’t that awesome?

    Myriad‘s counsel Benjamin Jackson

    This is actually pretty funny. Does anyone care what Myriad thinks about anything at this late stage in the game? It’s clear by now that Myriad will do and say anything to prop up their patent portfolio which, as everybody knows, includes much determine-and-infer junkola of the lowest order. Myriad and Sequenom are blood brothers here because — rest assured — whatever crack Sequenom manages to force open with their appeal, Myriad will immediately attempt to wedge their entire junky portfolio through it (the Supreme Court’s prior smackdown of their earlier attempts notwithstanding).

    With respect to the specific “arguments” in these briefs, Goldstein writes:

    [Under the Federal Circuit’s rule] the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel. . . . that cannot be correct.

    Of course it can be correct. Why can’t it be correct? “Phenomenon” are not eligible for patenting. Novel methods are eligible for patenting, provided they aren’t abstractions. Novel methods comprise novel steps (but the novelty can not lie in an abstraction, such as information, or in other ineligible subject matter). So Goldstein is wrong. The rule can be correct. Goldstein just doesn’t like that rule because the rule hurts his pocketbook. There. That was easy. Who’s next?

    the brief filed by Matthew Dowd on behalf of JYANT Tech, explaining that “in Diamond v. Diehr … the [Supreme] Court explained that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.”

    I don’t recall anybody arguing otherwise but it sure is a popular strawman among those who choose to remain confused about subject matter eligibility. Once again, for the record: I am aware of zero people who are arguing that a method comprising steps, wherein each step is (in isolation) in the prior art, is an ineligible method for that reason.

    So, let’s get right to addressing the core problems with Sequenom’s claim and the various legal positions set forth here:

    the industry organization 21st Century Medicine that challenges the “gist” method [<–another strawman] of determining whether a claim encompasses excluded subject matter and suggests that the claim here is simply a technological improvement over the prior art.

    There is no “technological improvement” in Sequenom’s claim because the claim recites using only old technology [i.e., PCR] to detect

    i)something that has always existed;
    ii)something that was in fact, known to exist based on common sense reasoning in view of the prior art which included the knowledge that where broken cells are found you can find DNA as well, and the knowledge that DNA was floating around in maternal blood (female Aliens may have molecular acid for blood, but not human females); and
    iii) something that was tailor-made for detection by PCR (in the generic sense, as recited in the claim), i.e., tiny levels of fetal DNA in maternal blood.

    Identifying a new phenomenon or fact or correlation and then using old technology to detect that phenomenon is not “new technology.” It’s using “old technology” for its intended purpose. Everybody knows that PCR (generally speaking) is capable of detecting tiny amounts of DNA wherever those DNA molecules happen to be. PCR doesn’t care where the DNA is from or what humans choose to call that DNA (e.g., “maternal DNA” or “bald eagle DNA” or “martian DNA”). If a detectable DNA molecule is there, PCR will detect it. If a detectable DNA molecule isn’t there, PCR won’t detect it (although it may yield a false positive in the case of contamination).

    That’s why if I discover a new species of frog, I can’t claim a method of using PCR to detect that frog’s DNA (or using a microscope to look at the “new” frog’s cells, or using a previously patented scalpel to cut open the “new” frog’s belly). It doesn’t matter that nobody knew that this specific frog’s DNA could be detected (beause they couldn’t possibly have known that!). Such a claim does not describe a patent-eligible “technological advance”. And it also doesn’t matter that my claim doesn’t “pre-empt” the frog. What matters — and the reason that the claim is ineligible — is that I can’t take an old detection method and turn it into a “new” detection method by identifying something “new” to be detected unless (and this is key) (1) there is clear teaching away from the theoretical possibility of detecting that “new” thing and (2) the claims recite the detailed solution that enables this “new” thing to be detected. Note that my hypothetical claim to the detection of this “new” frog’s DNA doesn’t fall into the exception (it doesn’t come close), and for the same reasons neither does Sequenom’s claim (it also doesn’t come close). Note as well that this is a restatement of the very reasonable rule that Sequenom argues “can’t be correct.” Of course it can be correct. More to the point, it is the correct rule and the public will find that out the hard way if the en banc CAFC and Supreme Court manage to resurrect these claims (yes, it’s happened before …).

    The other apt analogy that may be easier for non-bio folks to grasp would be claims to the generic use of an old telescope to detect “new” things in space by describing where to point the telescope. It’s the identical issue, presenting the identical problems as Sequenom’s “PCR this ‘new’ thing” claim, and the solution is the same: such claims are ineligible because they aren’t technological innovations. They are attempts to limit the public’s right to use old technology for its intended purpose.

    Consider: if Sequenom’s alleged “discovery” that fetal DNA existed in maternal blood is itself “new technology” worthy of patent protection, then why should Sequenom be limited to the use of just one old technology (i.e., PCR)? why should they not be entitled to claim any detection method? Or at least all detection methods in the prior art? (Myriad and Noonan are probably still searching under their couch cushions for an answer).

    Let’s say another party comes along and shows that it’s possible, using old technology, to detect DNA in maternal blood earlier than was previously thought. Do they “own” that discovery, as generically described? Let’s say another party comes along and shows that in certain women you can use “less” polymerase when performing this test. Do they “own” that discovery, as generically described? Let’s say another party comes along and shows that people with Ph.D.’s who perform the test obtain more accurate results. Do they “own” that discovery, as generically described? No. No. No. No.

    Now is the perfect time to address the ongoing confusion about “pre-emption” and where that concept fits into subject matter eligibility. Here’s the take-home lesson: “pre-emption” concerns are not solely driven by the breadth of the specific claim at issue (although sometimes that will be enough, if the claim is really broad, i.e., “I claim this phenomenon or this fact or this natural thing.”). Rather, “pre-emption” concerns are driven by the inevitable non-technological piling on by grifters and wannabe patent tr 0lls who identify bona fide technologies that are “hot” and salt their claims with ineligible subject matter (e.g., information and other abstractions or natural phenomenon).

    Although the purpose behind the test is preventing this preemption, the test itself seemingly does not ask whether preemption has occurred. In its brief, the NYIPLA argues that this fundamental question of preemption must be asked

    All that “needs to be asked” is whether the claim at issue is nothing more than a field-limited use of old technology. If so, it’s dead and ineligible. Is it obvious as well? Maybe. But the fact that a claim is obvious (or could be found so) certainly doesn’t mean that it isn’t also ineligible (as many dismayed folks know quite well at this late stage in the 101 debate).

    Some examples that may help folks who are trying to remain confused:

    Old technology: phone
    Claimed new use: communicating information about a special never-before-offered insurance rate plus a bonus gift of a set of steak knives

    Is the abstract concept of “phone communication” pre-empted? Of course it isn’t. Is the communication of abstract information about the insurance and steak knives “pre-empted”? Nope. Is the claim ineligible? Absolutely. See the explanation I provided above if you don’t understand why.

    Old technology: a processor for identifying likely customers, wherein said processor is hooked up wirelessly to a communication module
    Claimed new use: in response to the detection of a likely customer, automatically communicating information about a special never-before-offered insurance rate plus a bonus gift of a set of steak knives

    Is the abstract concept of using a computer to automatically communicate stuff to targeted people pre-empted? Of course it isn’t. Is the communication of abstract information about the insurance and steak knives “pre-empted”? Nope. Is the claim ineligible? Absolutely. See the explanation I provided above if you don’t understand why.

    Old technology: PCR
    Claimed new use: using PCR to detect blood of [insert list of specific identities of freshly born females]

    Same deal. Same result. Figure it out. It’s easy. If you have questions, ask.

    Old technology: camera
    Claimed new use: using a camera to take a picture of someone who is using PCR to detect fetal DNA in cell-free maternal blood

    Same deal. Same result. Figure it out. It’s easy. If you have questions, ask.

    1. 9.2

      the Supreme Court’s prior smackdown of their earlier attempts notwithstanding

      Except that the Supreme Court did not smack down all or even most of Myriad’s claims. The Supreme Court explicitly affirmed the §101 eligibility of the cDNA claims, and the Court was very careful to distinguish Myriad’s ineligible composition of matter claims from method claims that make use of the compositions of matter (133 S. Ct. at 2120):

      [T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.”

      In other words, according to the Supreme Court, claims about new applications of knowledge about naturally occurring matter are supposed to be eligible, even when the technology used to effect that application is admittedly old. That is what the Supreme Court said.

      Unfortunately, when faced with a situation about a claim to a method of using a different naturally occurring composition of matter (cffDNA), the CAFC reached for the wrong precedent (Mayo instead of Myriad), and thus arrived at the wrong outcome. That is why Sequenom correctly avers that the panel decision cannot be correct.

    2. 9.3

      I am aware of zero people who are arguing that a method comprising steps, wherein each step is (in isolation) in the prior art, is an ineligible method for that reason.

      Did you read the Sequenom panel opinion?

      “For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful.” Ariosa v. Sequenom, 115 U.S.P.Q.2d 1152, 1156 (Fed. Cir. 2015).

      It would appear that at least Judges Reyna & Wallach belong to this category of people.

    3. 9.4

      The other apt analogy that may be easier for non-bio folks to grasp would be claims to the generic use of an old telescope to detect “new” things in space by describing where to point the telescope. It’s the identical issue, presenting the identical problems as Sequenom’s “PCR this ‘new’ thing” claim, and the solution is the same: such claims are ineligible because they aren’t technological innovations.

      What is the utility in the “point the telescope this way” hypo? I agree that the proposed claim is §101 ineligible, but it is less clear to me that this is because of a common-law exception to §101 eligibility. The hypothetical claim here seems to me simply to fail the “useful” prong of “new and useful.”

      On the other hand, the Sequenom technology is very useful (hence why Ariosa was willing to spend so much litigating the claim through multiple appeals and remands). In other words, there is a material difference between your suggested hypo and the relevant claims. The analogy is not quite apt.

      1. 9.4.1

        As I have pointed out, Greg, when one engages in an inte11ectually honest way and does not try to obfuscate with either the the non-patent law utility (things outside of the Useful Arts), or with purely non-functionally related memes (the “gee, point a telescope or shine a flashlight), then – and only then – can a genuine dialogue move forward.

        But that would mean that certain people would have to stop their ad nauseum ad infinitum propaganda.

    4. 9.5

      MM, thanks for the summary of the briefs.

      This reminds me of the last ditch effort the Software Old Guard made in its briefs to the Supreme Court in Alice. In a nutshell, they argued the Rich dicta in Alappat that a programmed computer was per se eligible.

      Here the retreating Diagnostic Old Guard argues that any “application” of a discovery, however conventional, should be “enough” — relying on Diehr. They seem not to understand the principles involved. The application must be inventive — such that it brings something new to the table other than the discovery. Thus in Diehr, the inventors provided thermocouples inside the mold to continuously monitor the temperature and update the time ’til the mold should open. That was “new” and arguably inventive.

      With diagnostic methods involved here, everything is old but the discovery itself. There is no invention.

      1. 9.5.1

        In a nutshell, they argued the Rich dicta in Alappat that a programmed computer was per se eligible.

        As noted prior to the decision, Alappat was NOT AT ISSUE before the Court in Alice – regardless of what was or what was not in any brief submitted to the Court.

        Likewise, the Court said NOTHING about Alappat.

        Please kindly maintain at least a minimal level of inte11ectual honesty and not try to impliedly denigrate the Alappat decision.

        1. 9.5.1.1

          …and I will add that once again Ned confuses dicta and holding.

          Ned – the meaning of holding applies in Alappat because the government had argued in the alternative, and would have won the case had that alternative argument prevailed. Thus, the decision requires the reasoning to HOLD.

          This is basic stuff.

          Either you have blinded yourself to the necessary understanding in your pursuit of your agenda, or you truly are incapable of a basic legal understanding that a case can (and often must) have multiple holdings if any of a number of separate arguments would prevail otherwise.

          Ignorant or deceitful – not a great choice for you if you want to continue pushing for a clearly wrong view of the Alappat case.

  9. 8

    [Under the Federal Circuit’s rule] the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel. . . . that cannot be correct.

    That’s precisely correct. The federal circuit surprisingly got one right here. That’s exactly the result that comes from the Supreme Court test. It’s also the way the rule HAS to be. You can’t claim the “new knowledge” (as meant in this context) as that’s simply not an invention – the only thing that could be would be a method independently eligible.

    The confusion (or non-confusion, as it was likely intentional) is based upon the BACKWARD phrasing. When the question is properly phrased as “May we re-patent a previously known (and likely already patented) test by commanding it be applied to newly uncovered naturally occurring matter?” it becomes pretty easy to see the answer is no.

    Think of the craziness that would result from the opposite rule – You would have a flashlight that would be re-patented again and again based on shining it upon every new thing. Every system would be non-obvious (as it contains a novel, but by-itself ineligible element) and the flashlight qua flashlight would never fully enter the public domain. Especially when the “flashlight” is a diagnostic test and the “new thing” is everything the art discovers. Ditto any other “tool” such as statistics or mathematical equations.

    There was no “groundbreaking new diagnostic method” here as the petition suggests. There was a conventional, old diagostic method the subject of which is new non-eligible discovery of the fact that the mother’s plasma has fetal DNA in it. This is precisely the kind of e=mc^2 discovery that patent law is not designed to enforce. You simply cannot have a patent for conveying information of a fact about the world, which is the only thing of value conveyed in this specification.

    Question – If “apply it” isn’t eligible, why would “apply it, limited to the most commonly known method of applying it” be eligible? Especially when one could file 50 applications on the same day, each limited to a particular, conventional method of use without teaching the art anything new? Why would you think that you can achieve an aggregation of scopes that are valid when a single scope, BASED ON THE SAME DISCLOSURE, wouldn’t be valid? Wither Ultramercial, which used a particular (conventional) method rather than a general command?

    It’s not ridiculous to suggest that there must be some novelty/non-obviousness beyond the ineligible element in order to meet the eligibility test. If there isn’t, you’re going to end up granting patents solely because of the inclusion of ineligible elements, which wouldn’t make sense. That’s precisely what Sequenom is asking for here, isn’t it: This method would lack novelty and non-obviousness absent the ineligible element, but please reverse that holding because I have included the ineligible element.

    1. 8.1

      I suppose it bears mentioning that both Linn’s concurrence and the petition make much of the Diehr/Mayo “dissonance.”

      There is no dissonance. Mayo stated that post-solution activity that is “merely conventional or obvious” is not sufficient to make it eligible. Diehr had (though they didn’t use this term) a non-obvious pre-solution data gathering step because the prior art there did not previously continuously measure the temperature. (Whether that is truly non-obvious is suspect, to me at least) Diehr had a mathematical equation, but the invention was in the constant temperature measuring provided by novel non-obvious use of the thermocouple. The inclusion of an ineligible element (of math performed by the computer) did not defeat the otherwise patentable method.

      That is not true for either Mayo or this case, because the invention is entirely within the ineligible element. The inclusion of the ineligible element is clearly doing completely different work in this case, because the Applicants themselves admit they have nothing new otherwise:

      During prosecution of the application that became the ‘540 patent, the applicant stated:

      [O]ne skilled in the art is aware of a variety of techniques which might be used to detect different nucleic acid species. For example, there are numerous techniques which might be used to detect repeat expansions, single gene mutations, deletions or translocations. These techniques are a matter of routine for one skilled in the art for the analysis of DNA. J.A. 1052. The applicant went on to note:

      [O]ne skilled in the art is readily able to apply the teachings of the present application to any one of the well-known techniques for detection of DNA with a view to analysis of foetal DNA in paternal [sic] plasma or serum.
      J.A. 1055. Similarly, the applicant later added that “[t]he person skilled in the art has a broad range of techniques available for the detection of DNA in a sample.” J.A. 1057.

      I also don’t get how they completely ignore Alice, despite that case also having an old method that was only modified by an ineligible element.

      1. 8.1.1

        …maybe someone needs to learn that “the invention” is not “within” the element (“ineligible” or not).

        Elements – in and of themselves – do not carry “eligibility” as you are attempting to portray.

        Blindly chanting this type of canard (“Point of Novelty” in the 101 sense) does not make it law. It merely means that you are not cognizant that it is not law.

    2. 8.2

      RG: It’s not ridiculous to suggest that there must be some novelty/non-obviousness beyond the ineligible element in order to meet the eligibility test. If there isn’t, you’re going to end up granting patents solely because of the inclusion of ineligible elements, which wouldn’t make sense.

      Yup. And these people — particularly Dennis’ “old boss” Kevin Noonan — all know this. It was explained them years ago in the run-up to the Supreme’s 9-0 smackdown in Prometheus v. Mayo. It’s easy stuff to understand.

      But they didn’t want to talk about this basic fundamental stuff then and they don’t want to talk about now (even Dennis doesn’t like talking about it). Why? Two reasons: (1) they know where their bread is buttered; and (2) the good old boys club where the opinions of rich entitled people and their water carriers must be taken very, very seriously because, well, rich and entitled.

      The fact that it’s 2015 and people are still seriously questioning whether a claim reciting old detection technology can become patentable all over again by adding some ineligible subject matter to the claim is, frankly, appalling.

    3. 8.3

      Think of the craziness that would result from the opposite rule – You would have a flashlight that would be re-patented again and again based on shining it upon every new thing. Every system would be non-obvious (as it contains a novel, but by-itself ineligible element) and the flashlight qua flashlight would never fully enter the public domain.

      Huh? This makes no sense. The flashlight is not withdrawn from the public domain just because one possible use of the flashlight is patented. Your analogy proves exactly the opposite of the point you are trying to make.

      1. 8.3.1

        Imagine I own an old-fashioned Gutenberg-style movable-type printing press. The press itself is centuries-old technology and is decidedly in the public domain. Nevertheless, I am not permitted to use my press to print bootleg copies of Stephen King novels. Does this mean that Stephen King’s copyrights have pulled my printing press out of the public domain?

        1. 8.3.1.1

          And (gasp) loudly when the PROPER context of patents and being functionally related are embraced with inte11ectual honesty…

          Oops, that would have to mean that inte11ectual honesty was required for that dialogue…

        2. 8.3.1.2

          Nevertheless, I am not permitted to use my press to print bootleg copies of Stephen King novels. Does this mean that Stephen King’s copyrights have pulled my printing press out of the public domain?

          That’s not an accurate analogy though, because the natural phenomena is already owned by the public, while Stephen King’s book was always owned by him.

          A more accurate analogy would be that you have an old-fashioned Gutenberg-style movable-type printing press. The press itself is centuries-old technology and is decidedly in the public domain. You use the press to print many copies of a book that’s been in the public domain for years. Then one day the author of that book walks in with a gun and says that if you print another copy of that book he will shoot you. He has illegally impinged upon your right, as a member of the public, to do something and has pulled it out of the public domain.

          1. 8.3.1.2.1

            In the original analogy PCR was the flashlight. Now you are switching the analogy so that the natural phenomenon is the flashlight. Neither way does the analogy point in the direction you are arguing.

            The Sequenom claim does not withdraw the natural phenomenon from the public domain. Women are still quite free—even in view of Sequenom’s patents—to have cffDNA floating in their blood without fear of infringement suits. The only folks who have anything to fear from the Sequenom claims are people who do PCR or gene chips, neither of which could be plausibly construed as a “natural phenomenon.”

            1. 8.3.1.2.1.1

              Women are still quite free—even in view of Sequenom’s patents—to have cffDNA floating in their blood without fear of infringement suits.

              That’s a glib view of the rule. Morse’s claim didn’t prevent people from writing things down that someone shouted to them either, that didn’t stop his claim from being improper either.

              Besides your argument highlights your misunderstanding. Women are not only free to have cffDNA, women are also free to own the relationship between he cffDNA and what the cffDNA shows (ie the glimpse into what the fetal dna is). In the same way you can’t patent the relationship between energy and mass you cannot patent the relationship between cffDNA and fetal DNA. Women, as members of the public, are also free to utilize conventional methods of amplifying DNA whose patent terms have run.

              But despite them owning the amplifying method, the relationship between the method and its useful quality, the underlying cffDNA, and (for what it matters) technically they own the fetal DNA as well, you want to give the invention (which is nothing more than a combination of those things the woman already owns) to someone else.

              In the original analogy PCR was the flashlight. Now you are switching the analogy so that the natural phenomenon is the flashlight.

              Well I’m not sure what part of the printing machine scenario matches with the flashlight scenario, but it’s largely irrelevant anyway as the public owns all of the pieces. The fact that the pieces weren’t known doesn’t mean they weren’t owned, which is a completely different situation from someone who actually, you know, creates/invents something new.

              Patent law simply doesn’t respect the contribution made by this applicant. If someone filed a utility patent that claimed an old bus but had a great new manner in making it “pretty” you’d have the same situation – maybe the contribution is good, maybe it isn’t but its irrelevant because it isn’t the point of the forum. You do not get a patent for finding a characteristic of something already existing. That is not an inventive act. Nor is using known amplifying methods to amplify – the applicants admit that isn’t new. So I don’t know what you think they should get a patent for.

              1. 8.3.1.2.1.1.1

                But despite them owning the amplifying method, the relationship between the method and its useful quality, the underlying cffDNA, and (for what it matters) technically they own the fetal DNA as well, you want to give the invention (which is nothing more than a combination of those things the woman already owns) to someone else.

                Yes, I think that summarizes it nicely. I would quibble with the characterization “nothing more” for speciously trivializing the significance of the combination, but other than that, I agree entirely with your summary. I think that they should own a valid patent on using the conventional techniques (PCR, microarrays, FISH probes, etc.) to exploit the possibilities that this pre-existing natural relationship affords for diagnosis of disease.

                I don’t know what you think they should get a patent for.

                For the diagnostic method.

                1. Greg, when the only thing new is the discovery of a law of nature, the use of a conventional process with it is not invention.

                  Mayo.

                2. Dear Ned,

                  I agree that what you say is the law. I think that this is not statutorily correct, but I agree that Mayo says otherwise, and Justice Breyer writing for a 9-0 majority trumps me any day of the week.

                3. Greg, the case law is very consistent with the statute. One can only patent new or improved machines, etc.

                  A conventional process is not new. A conventional process is not improved.

                4. There is no improvement in being able to diagnose fetal genetic conditions with a blood draw from the mother instead of an amniocentesis? You have a rather odd view of what is or is not an improvement.

                5. Greg, the process itself, the only thing in the claim that is eligible subject matter, is conventional.

                6. 1, 3 – see Ned do it again.

                  (ps, “conventional” is not an eligibility argument, leastwise, not a proper one)

          2. 8.3.1.2.2

            I do not think that the 5.3.1.2 analogy is more accurate than my original analogy, but perhaps I am missing something. As I understand it, your objection is that there is this technology (PCR/printing press) that is in the public domain, and for many years the public is free to use it as they please. Then, suddenly, this second party arrives and says “if you use your prior art technology in this one, particular application, you infringe my IP right.”

            You find that objectionable, but I am not sure why it is objectionable in the case of Sequenom but not in the case of Stephen King.

            The response that “Stephen King’s book was always owned by him,” does not seem like it really gets at the distinction. After all, Stephen King’s book was not always owned by Stephen King. Stephen King did not own “Carrie” back in 1900, for the very simple reason that Stephen King was not born yet in 1900, and therefore had not yet written “Carrie.”

            If some owner of a Gutenberg press back in 1900 had wanted to string together the exact series of characters that amount to the novel “Carrie,” s/he would have been free to do so. By 1974 (the copyright date), however, this Gutenberg press owner was no longer free to string these characters together in that particular arrangement.

            It is no response to say “but the press owner did not know how to string those characters together in that arrangement back in 1900 because King had not yet taught us the value of that particular arrangement of characters.” By that logic, the same can be said of the Sequenom inventors. Sure, a molecular biologist in 1998 would be free to amplify cffDNA to diagnose prenatal genetic conditions, but no one had yet taught the molecular biologist that there would be any value in so doing, so that sort of PCR was not being done.

            Sequenom has not deprived the PCR-doing public of anything more than Stephen King has deprived the print-pressing-public: nothing.

      2. 8.3.2

        The flashlight is not withdrawn from the public domain just because one possible use of the flashlight is patented. Your analogy proves exactly the opposite of the point you are trying to make.

        That’s simply incorrect. There is a time after the flashlight’s patent term ends before the phenomena is uncovered that the public owns the right to use the flashlight in its conventional, patent-expired manner to illuminate the phenomena (which inherently belongs to the public). The patent withdraws that already-existing right from the public, rather than generating its own.

        1. 8.3.2.1

          The public “owns the right” to use the flashlight to illuminate an undiscovered cave that no one knows exists? I guess there is some sense in which those words are intelligible, but not any meaningful sense.

          The public is free to do everything after the claim that it would have been able to do before. Nothing has been taken from the public domain, and the public remains perfectly free to use the “flashlight” (PCR) in every manner they had been using it before.

          1. 8.3.2.1.1

            Greg,

            Note the “tone” of your post sounding NOT in 101, but in 102/103.

            Not that you are incorrect in what you say, but to highlight the easy path of obfuscation of those who are – on a very real sense – anti-patent, and require for their “position,” a certain level of obfuscating of the different sections of the law.

            1. 8.3.2.1.1.1

              I definitely agree that a lot of the disagreement over what is and what is not §101-eligible centers around a willingness or unwillingness to conflate §101 with §§102/103.

              I am definitely in the “unwilling” camp.

          2. 8.3.2.1.2

            Greg, If the “invention” is the discovery of the fact that paternal DNA could be found in the serum of a mother, why should the discoverer of this fact be limited to any particular method for the detecting the presence of paternal DNA in the blood serum?

            1. 8.3.2.1.2.1

              My apologies if I left the impression that I think the inventors here should be limited to PCR detection technology. I used PCR merely as an illustrative example. Mutatis mutandis, everything above would be equally applicable to microarray, FISH probes, etc.

          3. 8.3.2.1.3

            The public “owns the right” to use the flashlight to illuminate an undiscovered cave that no one knows exists? I guess there is some sense in which those words are intelligible, but not any meaningful sense.

            It’s only unintelligible if you don’t understand science or law. On what basis do you think that you have to know about something in order to own it? If you purchase land and later someone else figures out there is oil under your land, do you not own the oil? If you buy a second hand car because you think its in good shape but it turns out to be in need of repair, are you not liable for the repairs? If you purchase a house and all of its contents at a liquidation sale do you not own the contents just because you don’t know what they are?

            So let me ask you again – If I have the right to use a flashlight, and I have the right to go on land which I learn has a cave on it, do I have a right to use the flashlight in the cave?

            The public owns the amplification methods that have passed their terms. The public owns the cffDNA. *The public owns the previously unknown relationship between the cffDNA and the fetal DNA.* The public enjoyed that relationship just like it enjoys gravity before we even began to describe it. Someone doesn’t get to come along, provide detail to it, and deprive the public of what it already owned. That simply isn’t a feature of patent law.

            1. 8.3.2.1.3.1

              If I have the right to use a flashlight, and I have the right to go on land which I learn has a cave on it, do I have a right to use the flashlight in the cave?

              Well, definitely the prosaic answer to your question is “yes.”

              I am still not understanding your analogy, however. As best as I am able to follow, the flashlight is PCR/gene arrays/etc. The cave is the cffDNA. What is the land that I bought that had an undiscovered cave beneath it?

              The public owns the amplification methods that have passed their terms.

              Sure. Anyone who wants to can amplify the lacZ gene to their silly heart’s content and Sequenom cannot say “boo” about it.

              The public owns the cffDNA.

              Definitely. I can assemble great vats of cffDNA if it tickles my fancy without intruding on any of Sequenom’s IP rights.

              *The public owns the previously unknown relationship between the cffDNA and the fetal DNA.* The public enjoyed that relationship just like it enjoys gravity before we even began to describe it.

              Sure. If my wife were carrying around some cffDNA in her blood while were expecting our various children, and one or more fragments of that cffDNA had betokened some genetic condition, this state of affairs would not have engendered any sort of liability.

              Someone doesn’t get to come along, provide detail to it, and deprive the public of what it already owned. That simply isn’t a feature of patent law.

              I agree. I do not agree, however, that this what Sequenom did. They provided a diagnostic method. That diagnostic method is a process, but it is not the natural phenomenon itself. The only connection between Sequenom’s diagnostic method and the natural correlation is that the diagnostic method makes use of the natural phenomenon, but then so do all inventions.

  10. 7

    “A new property discovered in matter, when practically applied in the construction of a useful article of commerce or manufacture, is patentable; but the process through which the new property is developed and applied must be stated, with such precision as to enable an ordinary mechanic to construct and apply the necessary process. A patent will be good though the subject of it consists in the discovery of a great general and most comprehensive principle in the science or law of nature, if that principle is, by the specification, applied to any special purpose, so as thereby to effectuate a practical result and benefit not previously attained.

    Leroy v. Latham. Circuit Court, Southern District of New York,1853

  11. 6

    Dear hyperventilating maroons.

    A group of people discovered the Higgs Bosun. They don’t get to patent it. It’s not NEW.

    Someone discovered graphene. It’s not patentable. It’s not NEW.

    Persons discovered fetal DNA in maternal blood samples. It’s not patentable. It’s not NEW.

    It already exists in nature.

    DEAL WITH IT!

    1. 6.1

      ^ Factual, because the people who discovered a pre-existing truth want to make money they think the tail wags the dog, and that therefore the conclusion must be that its eligible because we want money for the unpatentable discovery.

      1. 6.1.1

        Much hay will be made out of the “importance” of the “discovery” underlying Sequenom’s claims.

        Little hay will be made out of the fact that Sequenom made its discovery using a great innovation which is now in the public domain but, if the petitioners here have their way, will be effectively taken out of the public domain by the inevitable filing of “I discovered this with PCR therefore I own the use of PCR to look at this” claims.

        Even less hay will be made out of the obvious fact that PCR is just one of a nearly infinite number of public domain or previously disclosed detection methods that can easily be locked up in reams of “I discovered ineligible phenomenon X and I now claim the use of old methods to study X” patents.

        Those “discoveries” that show up in those junky claims are not always going to be “important”. On the contrary, nearly all of the time they are going to be trivial, bordering on the absurd (“Old communication modules can communicate information about information rates and bingo games? Wowee zowee! Who’d a thunk it?”). But the junk quickly adds up and the damage done to the patent system is severe. If anyone doubts that, take a look at the patent bubble, observe the junk that has flowed out of the PTO for the past decade or two, and remember the crazee class of Texan b0tt0m-feeders that junk has enabled.

    2. 6.2

      Funny. Your analysis above shows exactly why your reasoning, as well as the panel’s reasoning, is incorrect. The inventors are not trying to patent “fetal DNA in maternal blood samples.” Rather, they discovered that you can use a naturally occurring phenomenon in a process to achieve a useful end. Just like using naturally occurring taxol to treat cancer. Not claiming taxol. Just claiming a method of using taxol.

      1. 6.2.2

        No. They are claiming every medical application of the sap of the Yew Tree where they found Taxol.

        1. 6.2.2.1

          Not true, and again your response illustrates your mistaken impression of the claim. To continue with the analogy, they are claiming the use of the yew tree sap, but only that which is isolated in a particular novel and nonobvious way. Others are free to use yew tree sap isolated by traditional methods.

          Applied to the case, others are free to analyze fetal DNA to make the very same determinations (e.g., gender identification) through traditional means, such as amniocentesis and chorionic villi sample.

  12. 5

    The real test is largely some version of “I know unpatentable subject matter when I see it;” the paper test is trying to treat the Alice opinion as if it articulated some kind of coherent legal principle that can be applied consistently in other cases.

    This patent passed the real test but failed the paper test, so here we are…

    1. 5.1

      the paper test is trying to treat the Alice opinion as if it articulated some kind of coherent legal principle

      Translation: “Alice harms my favorite patents therefore it’s not coherent.”

      Unfortunately, DCL, we’ve already seen you and your cohorts play this game before. You did it in Prometheus v. Mayo which was also sooooooo “confusing”.

      The legal principle really isn’t that confusing. It’s actually pretty straightforward and it makes a lot of sense.

      Of course if certain people refuse to discuss or attempt to understand the principle then it’s not surprising that the “followers” of those people will remain confused.

      Educate yourself.

    2. 5.2

      That’s my problem, too. If you take the claims that the PTO assumes are patentable and compare those with the claims the PTO assumes are not patentable based on Alice, I personally get confused. I cannot determine the line between what’s patentable and what’s not.

      1. 5.2.1

        Can you say “void for vagueness”…?

        (and please note that that concept is NOT limited to criminal matters, and very much applies where property rights are at stake)

      1. 4.2.1

        Warning: anon’s video link contains material some may find objectionable (language, nudity).

        I’m not sure what patent-law related point anon (or perhaps sister-anon) is attempting to make with this video link to a scene from The Breakfast Club, but it seems to me that it contributes little to the discussion quality.

          1. 4.2.1.3.1

            ^^^ and away we go with the nym theft and purposeful misleading posts…

            (it’s not like you cannot use the “anon” tag, my friend, it is how you intend to paint a false picture with that use)

      1. 4.3.1

        (the perception that someone “piled it on” the professor is inescapable – as is the irony)

  13. 3

    Points 1 and 1.1 are valid. Another problem is if the same firm is preparing both applications at more or less the same time. Then, whichever attorney at the same firm happens to file his/hers first would be to the detriment of the other client. Even if the inventions aren’t the same (which is clearly a conflict), in the same field could mean one would still be relevant prior art to the other. I don’t see a problem though if application X for client x was already filed and then client y comes and asks for application Y in the same technical field after X was already filed (assuming the attorney can avoid any inadvertent “spilling” of confidential info from one client’s application to the other).

    Notwithstanding these points, the position the brief takes is generally correct. For a law firm to be only able to represent a single client in each technical field would require the breakup of all of the large IP firms. Further, an independent inventor would probably not be able to find representation (unless hiring some bozo advertising on Google for $999 patent applications).

    It should be up to the individual firms to police for all of these situations when they arise and then withdraw when necessary.

  14. 2

    “Ugh” is correct. The brief also left out the situation where client A’s patent is cited against client B’s application, and I need to tell the PTO that the A patent does not disclose “xxx” in order to overcome the rejection of B. I can’t ethically do that, diss my own client’s patent. This brief ignores the issue and thus is misleading and an incorrect statement of the law. I assume that it is knowingly and intentionally misleading, as it comes from a bunch of big shot high powered people. Ugh.

  15. 1

    Ugh. If I read the amicus brief correctly, the firms only identified interferences as source of conflict. The real problem of course is infringment, where one attorney knows that advancing claims of a certain scope will read on the products or services of another client.

    (This actually happened to me while prosecuting a case for one client where I knew the claims would read on the products of the other. At my urging, we dropped representation of one of the two clients.)

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